№ lp_1_2_10425
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File size: 362 KB
Comprehensive procedural guide detailing the steps and responsibilities for conducting clinical trials, managing registries and biobanks, including recruitment, consent, record keeping, and reporting of incidents.
Year:
2021
Organization:
Canberra Health Services
Document Type:
Procedure Manual
Scope:
Clinical trials, registries, and biobanks
Author:
Clinical Trials Unit
Version:
1.0
Issue Date:
19/09/2021
Amendment History:
Initial Release
Target Audience:
CHS staff involved in clinical trials
Procedures Covered:
Recruitment, informed consent, record management, specimen handling, complaints management, safety reporting
Price: 8 / 10 USD
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Year:
2021
Region / City:
Canberra
Theme:
Clinical Trials, Research Procedures
Document Type:
Procedure Manual
Organization:
Canberra Health Services
Author:
Clinical Trials Unit
Target Audience:
CHS Staff involved in clinical trials
Period of Effect:
Indefinite
Approval Date:
17/09/2021
Amendment Date:
Not specified
Document Status:
Controlled, subject to updates
Year:
2021
Region / City:
Canberra
Theme:
Clinical Trials, Research Procedures
Document Type:
Procedure Manual
Organization:
Canberra Health Services
Author:
Clinical Trials Unit
Target Audience:
CHS Staff involved in clinical trials
Period of Effect:
Indefinite
Approval Date:
17/09/2021
Amendment Date:
Not specified
Document Status:
Controlled, subject to updates
Year:
2024
Note:
Region / city
Topic:
Clinical Case Registries, Software Documentation, Security Guide
Document Type:
Technical Manual
Year:
2020
Country:
Ethiopia
Project:
The Support for Capacity Development of the AUC and other AU Organs Project (P126848)
Purchaser:
The Africa Union Commission (AUC)
Grant No.:
IDA-D3550
RFB Reference No.:
ET-AUC-175216-GO-RFB
Location of Delivery:
Malawi, Botswana, Rwanda, Ivory Coast
Date Issued:
August 28, 2020
Bid Submission Deadline:
October 6, 2020
Type of Document:
Request for Bids
Target Audience:
Eligible international bidders
Procurement Method:
International Competitive Procurement
Source of Funding:
World Bank
Description:
This document outlines the bidding process for the supply and installation of data infrastructure systems in four African countries as part of a broader capacity development project by the African Union Commission.
Year:
2019
Note:
Region / City
Subject:
Healthcare Software
Document Type:
Release Notes
Target Audience:
Healthcare professionals, system administrators
Description:
This document describes the release notes for the Clinical Case Registries (CCR) software, including patch details and changes in version 1.5.34.
Year:
2013
Region / City:
United States
Subject:
Cancer Surveillance
Document Type:
Program Justification Statement
Organization / Institution:
Centers for Disease Control and Prevention (CDC)
Author:
Reda J. Wilson, MPH, RHIT, CTR
Target Audience:
CDC-funded central cancer registries, public health professionals
Effective Period:
2013-2016
Approval Date:
March 21, 2013
Modification Date:
Not specified
Year:
2010-2017
Region / City:
Africa, Latin America
Topic:
Colorectal Cancer, Cancer Registries
Document Type:
Statistical Table
Institution:
Various Cancer Registries
Authors:
Not specified
Target Audience:
Researchers, Medical Professionals
Period of Validity:
2010-2017
Date of Approval:
Not provided
Date of Revisions:
Not provided
Year:
2012
Organization:
Centers for Disease Control and Prevention (CDC)
Program:
National Program of Cancer Registries (NPCR)
Document Type:
Security overview / guidance
Audience:
Central Cancer Registries, IT Security Officers, Department of Veterans Affairs, Department of Defense
Modules Covered:
Web Plus, CRS Plus, Prep Plus, other Registry Plus modules
Certification:
HHS C&A Level III for Registry Plus modules
Standards Referenced:
NIST controls
Document Author:
CDC Registry Plus Development Team
Related Links:
CDC NPCR data security resources, Web Plus security features, vulnerability management lifecycle
Purpose:
Guidance on implementing and auditing security policies specific to cancer registries
Year:
1937
Region / city:
South West Africa
Subject:
Deeds Registration
Document Type:
Legislative Act
Organization / Institution:
Government of South Africa
Author:
South African Government
Target Audience:
Legal professionals, Government officials
Period of Effect:
Ongoing
Approval Date:
1937
Amendment Dates:
1953, 1956, 1957, 1962, 1964, 1965, 1967, 1969, 1972, 1976, 1979, 1985
Modification History:
Amended several times between 1953 and 1985
Year:
2018
Region / city:
Northern Ireland
Topic:
Cancer survival trends, international comparison
Document type:
Research paper
Organization / institution:
NICR
Author:
Claudia Allemani, Tomohiro Matsuda, Veronica Di Carlo, Michel P Coleman, et al.
Target audience:
Health professionals, researchers, policymakers
Effective period:
2000–2014
Approval date:
Not specified
Date of changes:
Not specified
Journal:
Lancet
DOI:
doi.org/10.1016/S0140-6736(17)33326-3
Funders:
International contributors including Cancer Focus and Public Health Agency via NICR
Conclusion:
International differences in cancer survival exist
What this means for the service:
Northern Ireland compares well for cancer survival internationally but not when compared to similar countries in Europe.
Year:
2024
Region / City:
Pretoria
Subject:
Court Schedules
Document Type:
Court Listing
Institution:
Gauteng Division, Pretoria
Target Audience:
Legal professionals, Court staff
Period of Validity:
20 February 2024
Approval Date:
20 February 2024
Date of Changes:
N/A
Jurisdiction:
Australia
Regulatory framework:
Therapeutic Goods Administration (TGA) Clinical Trial Notification scheme
Document type:
Regulatory notification form
Scope:
Clinical trials involving medicines, biologicals, medical and therapeutic devices
Trial phases covered:
Phase I–IV, bioavailability/bioequivalence, device studies
Subjects:
Human participants
Ethics oversight:
Human Research Ethics Committee (HREC)
Approving authority:
Relevant institutional authority
Geographic coverage:
Australian trial sites with optional international sites
Responsible party:
Lead Investigator
Fee responsibility:
Lead Investigator
Related institution:
La Trobe University
Submission requirement:
Completed form and ethics approval
Note:
Year
Subject:
Clinical Trials, Medical Research
Document Type:
Template
Organization / Institution:
EU Clinical Trials Expert Group
Target Audience:
Sponsors of clinical trials
Document type:
Instructional guidance
Subject:
Informed consent forms in clinical research
Context:
Clinical trials involving human participants
Regulatory and ethical framework:
Research ethics and regulatory compliance
Organizations referenced:
Children’s Oncology Group; National Cancer Institute; National Institutes of Health; OCREB
Funding context:
Public funding by the National Cancer Institute
Intended audience:
Consent form authors; clinical trial investigators; participating centres
Geographic scope:
North America
Population referenced:
Children and adolescents with cancer; parents or legal guardians
Related materials:
Provincial informed consent form templates; lay terminology glossary
Year:
2025
Region / city:
Ireland
Topic:
Clinical trials, Primary care, Research funding
Document type:
Request Form
Organization / institution:
Health Research Board
Author:
HRB Primary Care Clinical Trials Network
Target audience:
Lead Investigators in clinical trials
Effective period:
Until November 2026
Approval date:
N/A
Date of amendments:
N/A
Year:
2024
Region / City:
N/A
Topic:
Critical Appraisal
Document Type:
Checklist
Organization / Institution:
Critical Appraisal Skills Programme (CASP)
Author:
Critical Appraisal Skills Programme (CASP)
Target Audience:
Healthcare professionals, researchers
Date of Approval:
N/A
Date of Modification:
N/A
Note:
Year
Document type:
Template
Institution / organization:
EU Clinical Trials Expert Group
Target audience:
Sponsors of clinical trials
Year:
2023
Region / City:
Rwanda
Theme:
Clinical Trials, Good Clinical Practice (GCP) Inspection
Document Type:
Guidelines
Organization / Institution:
Rwanda Food and Drugs Authority (Rwanda FDA)
Author:
Dr. Emile BIENVENU
Target Audience:
Clinical trial regulators, researchers, pharmaceutical professionals
Period of Validity:
Starting from 23/07/2021
Approval Date:
20/05/2021
Date of Revision:
06/01/2023
Year:
2018
Region / City:
Melbourne
Subject:
Clinical Trials, Monitoring, Investigator-Initiated Trials
Document Type:
Template
Organization / Institution:
Melbourne Children’s Trials Centre, Clinical Research Development Office (CRDO)
Author:
Not specified
Target Audience:
Sponsor-Investigators, Clinical Research Professionals
Effective Period:
Not specified
Approval Date:
01 May 2018
Date of Changes:
Not specified
Note:
Year
Subject:
Clinical Trials, FDA, NIH, IND, IDE
Document Type:
Template
Organization / Institution:
National Institutes of Health (NIH)
Target Audience:
Clinical Researchers, Investigators